September 1, 2002
The EU Directive on Food Supplements passed into law recently, and Directives on fortified foods and health claims will follow. Reporting from Brussels, regulatory expert Stefanie Geiser explains Europe's new legislative environment and highlights its significance for the industry.
Over the past 10 years, manufacturers and distributors of food supplements and functional foods have been faced with a multitude of barriers to trade and unpredictable changes in the regulatory environment for marketing their products in Europe. While marketing problems in the past have revolved around the divergence of national legislation, increased EU momentum toward the creation of a single European market in nutritional products has created an environment in which companies need to adapt their products to a combination of national and EU rules.
This year's adoption of the EU Directive on Food Supplements has been the most significant regulatory change at the EU level so far. Although the Directive at this stage deals with only vitamins and minerals, it establishes a range of general principles and labelling requirements that will affect food supplement products containing other ingredients. It will also have a significant influence over future legislation related to fortified and functional foods. A draft proposal for an EU regulation on nutrition, functional and health claims was published in June 2002. By winter, the European Commission is expected to develop a revised version of its proposal for a draft Directive on the addition of nutrients to foods.
The new EU legislation will affect the marketing of products within the European market in three major ways:
New EU labelling rules for all food supplements. These include specific labelling statements (such as the requirement to mention the word 'food supplement' on the label); compulsory warning statements (e.g., storing out of reach of children); and specific nutrition labelling rules.
Harmonised EU rules on the type of vitamin and mineral substances that may be used. These were formerly regulated at national levels. The Directive sets out a positive list of 112 vitamin and mineral substances that may be used in all EU member states. Other vitamin and mineral substances are not permitted unless both a safety dossier for EU approval is submitted to the Scientific Committee on Food (SCF) within the next three years and, until EU approval is granted, a member state has provided a national exemption for their use, which is limited to a maximum of seven years.
Potential changes in national notification/registration systems. The Directive sets out an option for member states to introduce or maintain the requirement for product notification.
The timing for these changes is as follows:
As of July 2003, products meeting the above-mentioned labelling and compositional rules will be permitted. Member states are therefore requested to implement the EU Directive into national law by this date.
By July 2005, all products need to follow the new labelling rules and may contain only listed vitamin and mineral substances or those for which a national exemption has been provided.
Food supplement ingredients other than vitamins and minerals will continue to be subject to national rules. A positive list of other ingredients is likely to be drafted by the European Commission at a later stage and then included in the EU Directive.
In relation to health claims and fortified/functional food products, no changes are expected at the EU level within the next two to three years, because EU rules are still in the drafting process. At this stage, at least, the national divergences between European countries will remain.
What Does It All Mean?
The challenges facing companies over the next three years relate principally to the marketing of food supplements.
All food supplement products on the EU market will need to be relabelled to accord with the new EU rules, and reformulation will be required for those products containing nonlisted vitamins and minerals (except if these are in the EU approval process within the next three years). Companies should therefore submit a safety dossier for nonlisted vitamin and mineral substances to the SCF as soon as possible to keep open the possibility of gaining national exemptions for their use. The exemption is good for seven years, if no EU approval is granted in the meantime.
With the maximum limits for vitamins and minerals not yet established, reformulation and relabelling issues remain. But these limits are next up for resolution within the EU Directive. The adoption of these levels is certain to be controversial, with pressure coming from member states for either higher or lower levels. Should the Commission adopt maximum limits within the next one to three years, companies using vitamins and minerals exceeding these final limits would be obliged to reformulate and consequently also to relabel their products for a second time.
It is unlikely that multiple reformulation and relabelling will be necessary for many food supplements currently on the market. However, companies that market higher-dose products have more complex issues to resolve, particularly if they are using vitamins and mineral sources not on the current EU list. Some of these companies might consider waiting as long as possible for the adoption of EU maximum limits before introducing changes to their product formulas and labels.
Launching New Products
Companies seeking to launch new products are currently faced with an intermediate transition period. This means they need to negotiate established EU rules on labelling and vitamin/mineral substances as well as divergent national rules on other product ingredients and health claims . In view of the pending EU decision on maximum limits, companies should be aware that they might be faced with reformulation at some stage.
One advantage of the EU Directive is that it finally opens up the possibility for the launch of pan-EU vitamin/mineral formulas, because common national restrictions on the use of vitamins A and D and many minerals will have been removed.
What's Next: Food Supplements
Within the next seven years, the SCF will be evaluating those new vitamin/mineral dossier submissions that have been provided by July 2005. This should extend the list of approved vitamin and mineral substances. Within this period, member states can provide a national exemption for the use of these substances.
The European Commission is still awaiting the final opinion of the SCF on the establishment of maximum limits for vitamins and minerals. The final SCF risk assessment data is expected for publication in 2003. It is, however, still uncertain when and how the European Commission and member states will be making a final decision on the risk management of this data. The Directive mentions that maximum limits should be set by taking into account SCF-recommended upper safe levels and intakes of vitamins and minerals from other dietary sources. Intakes of vitamins and minerals for the population (i.e. RDAs) may also be taken into account.
Further issues to be clarified in the EU Directive are related to the development of purity criteria, nutrient overages and the revisions of EU labelling of RDAs for vitamins and minerals.
Once all issues related to vitamins and minerals are resolved, the European Commission will then look into the development of specific food supplement rules for other ingredients, such as amino acids and herbs. As a first step, the Commission will be drafting a positive list of other ingredient categories and substances by 2007.
What's Next: Fortified Foods
The European Commission plans to issue a revised version of its draft proposal for an EU Directive on the addition of nutrients to foods by the end of the year. It is likely that this proposal will include a positive list of all permitted nutrients. The Commission has not yet decided whether to introduce specific restrictions on the addition of nutrients to certain food categories. Maximum limits will also be subject to further discussions.
What's Next: Health Claims
In June 2002, the Commission issued draft regulations on health claims. The proposal currently covers nutrition claims, functional claims and health claims. Health claims are further divided into two categories. One is enhanced function claims, which refer to "a specific beneficial effect, beyond that normally obtained from the diet, on physiological functions of the body." The second is reduction of disease risk factor claims, which refer to a food or food constituent that "significantly reduces a major risk factor in the development of a human disease."
While established nutrition and functional claims could be used without special authorisation, the current draft sets out the requirement for a premarketing approval of health claims with the European Food Safety Agency (EFSA).
The text was subject to public consultation in July and will now go into interservice consultation within the European Commission, which may finalise its draft by the end of the year, meaning that first discussions in the Parliament could take place some time in 2003.
Opportunity Or Threat?
From a national marketing perspective, the effect of the new rules will depend on the existing regulatory environment within each EU country. While there may be some restrictions for the more liberal markets such as the UK and the Netherlands markets, harmonised legislation on vitamins and minerals should create an opportunity for a wider range of products to be sold in more restrictive markets such as France, Germany and Spain.
For example, the EU Directive on Food Supplements will remove restrictions on the use of food supplement ingredients such as vitamins A and D and minerals such as chromium, copper, manganese, molybdenum and selenium that exist in many countries. By setting standards for the use of these ingredients, the Directive is removing daunting barriers to trade, making it possible to create pan-EU formulas and label formats.
Internationally, it is hoped that new EU rules will bring increased opportunities for the pan-EU marketing of products. Three key developments for this to happen will now be:
For food supplements, the development of acceptable EU maximum limits for vitamins and minerals.
For fortified/functional foods, limited restrictions on the types of foods and ingredients that may be used for food fortification in the draft EU Directive on the addition of nutrients to foods.
For food supplements and functional foods, acceptance of disease risk-reduction claims by new EU health claims rules.
Harmonised rules for all nutritional products may be a long way off, but now is the time for companies to begin positioning themselves to take advantage of the new EU rules in light of these changes.
The new EAS report, "Marketing Food Supplements, Fortified & Functional Foods in Europe—Legislation and Practice 2002," provides more details on these recent EU developments and the national rules of 20 European countries. For more information on the 140-page report, priced 495 euros (US$495), and EAS services, visit www.eas.be or contact:
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Tel: +322 218 1470, Fax: +322 219 7342
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